Fluid containment apparatus

ABSTRACT

The invention relates to the treatment of wounds. In particular, the invention relates to systems, devices, and methods enabling pulse lavage irrigation of wounds in a non-controlled setting while providing containment of contaminated irrigation fluid, thereby preventing exposure of individuals and surfaces in proximity to the patient to infectious materials.

This application claims priority to U.S. Provisional Application Ser.No. 61/109,360, filed Oct. 29, 2008, which is hereby incorporated byreference in its entirety.

FIELD OF INVENTION

The invention relates to the treatment of wounds. In particular, theinvention relates to systems, devices, and methods enabling pulse lavageirrigation or pressurized non-pulsatile irrigation of wounds in anon-controlled setting while providing containment of contaminatedirrigation fluid, thereby preventing exposure of individuals andsurfaces in proximity to the patient to infectious materials.

BACKGROUND

Chronic wounds have an enormous impact on the US population. Between1.3-3 million US individuals suffer from pressure ulcers (Kuehn (2007)JAMA 297:938-9; herein incorporated by reference). Of the 20 millionAmericans with diabetes, approximately 10-20% are at risk for developingdiabetic ulcers (Kuehn (2007) JAMA 297:938-9; herein incorporated byreference). Many millions more suffer from venous stasis ulcers,lymphedema, peripheral vascular disease, non-healing surgical wounds,and burn wounds. It is estimated that between 5-10 billion dollars arespent annually in the US on wound care for chronic wounds (Kuehn (2007)JAMA 297:938-9; herein incorporated by reference).

By nature, all wounds contain some degree of bacteria. Wounds withincreasing bacterial counts are said to be contaminated, then colonized,then critically colonized, and when the amount of bacteria exceeds 10⁵per gram of tissue, the wound is said to be “infected” although it mayor may not display the classic characteristics of infection such asfrank pus, inflammation, and erythema. Although grossly infected woundsmay represent a situation that requires more urgent intervention, it hasbeen demonstrated that any amount of bacteria in a wound is detrimentalto wound healing. Acute infections may occur in “fresh” acute wounds orin chronic wounds and may lead to tissue loss, limb loss, sepsis, oreven death.

The effect of bacteria on wound healing is multifactorial, the sum ofwhich is referred to as the bioburden. In general, the bacteria competewith the host for oxygen and nutrients, and create a pro-inflammatoryenvironment that resists host defenses and places a metabolic strain onthe wound. Normal growth factors and other pro-healing mechanisms may behindered or even degraded by the bacteria, the end result of which isthat wound healing is greatly prolonged. Over time, through adhesion toeach other and the secretion of a proteinaceous matrix, the bacteria mayform a biofilm which may be resistant to further treatment (Galiano etal (2007) in Grabb and Smith's Plastic Surgery, Lippincott Williams &Wilkins, Philadelphia, Pa.; herein incorporated by reference).

Since the early 1900s, the mainstay of wound treatment has beenirrigation and mechanical debridement. This technique decreasesbacterial counts and removes foreign bodies and necrotic tissue in whichbacteria can proliferate, and thus aids wound healing, decreases theincidence of infection, and reduces the bioburden of the wound.

As adjuncts to mechanical debridement and irrigation, there arecurrently several different types of chemical debridement andantimicrobial agents that are used to decrease bacterial counts andremove necrotic tissue. However, the efficacy of these agents inremoving biofilm and debriding necrotic tissue is minimal, as they donot penetrate the wound eschar and thus cannot reach the places wherebacteria may reside.

Negative pressure wound therapy (NPWT) is a recent advancement in woundcare. Among other beneficial actions, NPWT devices help remove bacteriaand their secreted enzymes, thereby reducing bacterial counts andsubsequently aiding wound healing. However, NPWT devices should not beused if necrotic tissue or active infection is present, and will notremove a biofilm or eschar. In addition, these devices are not meant tobe used in areas under pressure (such as in a sacral pressure sore) andalso require a cavity or indentation in the skin, which limits their usein superficial wounds.

Pulse lavage irrigation has been developed over the last 40 years andhas been repeatedly shown to effectively decrease bacterial counts inwounds more efficiently and effectively than conventional methods ofirrigation, including bulb syringe irrigation or gentle lavage, and isas effective at reducing bacterial counts as tangential hydrodissection(Granick et al (2007) Ostomy Wound Manag. 53:64-6, 68-70, 72; hereinincorporated by reference). Pulse irrigation can be used in wounds ofany depth or level of bacteria. At moderate pressures, pulse irrigationis non-injurious to viable tissue. In a small scale study using acaprine wound model and bioluminescent strain of Pseudomonas aeruginosa,pulse irrigation was shown to reduce bacterial counts more effectivelythan bulb irrigation (Svoboda et al (2006) J Bone Joint Surg. Am.88:2167-74; herein incorporated by reference). Finally, pulse lavage hasbeen shown to be more effective than whirlpool therapy in reducingbacterial counts (Krasner et al (2007) Chronic wound care: A clinicalsource book for healthcare professionals, 4^(th) ed, Alvern Pa., HMPCommunications 331-342).

The major drawback to pulse lavage is that it is extremely messy and caneasily contaminate the patient's surroundings, putting other patientsand the person administering the treatment at risk. There have been casereports of pulse lavage irrigation spreading bacteria between patients(Maragakis et al (2004) JAMA 292:3006-11; herein incorporated byreference). Consequently, pulse lavage must be administered in acontrolled environment. This limits the availability of pulse lavage asa therapeutic option and renders it unpracticable at the bedside, inhome care and outpatient settings, and in military or fieldenvironments.

There is need in the art for improved methods of administering containedpulse lavage irrigation or contained pressurized non-pulsatileirrigation to aid wound healing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of a device. A, upper housing element; B,base element; C, wound-proximal membrane. Elements are shown in aseparated state and are in an assembled state during wound irrigationtherapy.

FIG. 2 shows several non-limiting exemplary embodiments for the upperhousing element connection to the base element. A, screw structure (e.g.threading); B, interlocking structure (e.g. lock-in place); C,notched-fit.

FIG. 3 shows non-limiting exemplary embodiments for the base memberconnection to the wound-proximal membrane.

FIG. 4 shows an embodiment of the wound-proximal membrane component.

FIG. 5 shows non-limiting exemplary embodiments of: A, suction port(s);B/C, irrigation nozzle element(s); and D, plug elements.

FIG. 6 shows several non-limiting exemplary embodiments of the basemember element and upper housing element, and connection thereof.

DEFINITIONS

As used herein, the term “wound” refers broadly to injuries to tissueincluding the skin, subcutaneous tissue, muscle, bone, and otherstructures initiated in different ways, for example, surgery, (e.g.,open post cancer resection wounds, including but not limited to, removalof melanoma and breast cancer etc.), contained post operative surgicalwounds, pressure sores (e.g., from extended bed rest) and wounds inducedby trauma. As used herein, the term “wound” is used without limitationto the cause of the wound, be it a physical cause such as bodilypositioning as in bed sores or impact as with trauma or a biologicalcause such as disease process, aging process, obstetric process, or anyother manner of biological process. Wounds caused by pressure may alsobe classified into one of four grades depending on the depth of thewound: i) Grade I: wounds limited to the epidermis; ii) Grade II: woundsextending into the dermis; iii) Grade III: wounds extending into thesubcutaneous tissue; and iv) Grade IV: wounds wherein bones are exposed(e.g., a bony pressure point such as the greater trochanter or thesacrum). The term “partial thickness wound” refers to wounds that arelimited to the epidermis and dermis; a wound of any etiology may bepartial thickness. The term “full thickness wound” is meant to includewounds that extends through the dermis.

As used herein, “wound site” refers broadly to the anatomical locationof a wound, without limitation.

As used herein, the term “acute wound” refers to a wound that has nothealed within 30 days.

As used herein, the term “chronic wound” refers to a wound that has nothealed in a time period greater than 30 days.

As used herein, the term “subject” refers to both humans and animals,including, but not limited to, a dog, cat, bird, livestock, andpreferably a human.

As used herein, the term “dressing” refers broadly to any materialapplied to a wound for protection, absorbance, drainage, treatment, etc.Numerous types of dressings are commercially available, including films(e.g., polyurethane films), hydrocolloids (hydrophilic colloidalparticles bound to polyurethane foam), hydrogels (cross-linked polymerscontaining about at least 60% water), foams (hydrophilic orhydrophobic), calcium alginates (nonwoven composites of fibers fromcalcium alginate), and cellophane (cellulose with a plasticizer) (Kannonand Garrett (1995) Dermatol. Surg. 21: 583-590; Davies (1983) Burns 10:94; each herein incorporated by reference). The present invention alsocontemplates the use of dressings impregnated with pharmacologicalcompounds (e.g., antibiotics, antiseptics, thrombin, analgesiccompounds, etc). Cellular wound dressings include commercially availablematerials such as Apligraf®, Dermagraft®, Biobrane®, TransCyte®,Integra® Dermal Regeneration Template®, and OrCell®.

As used herein, “treatment environment” refers broadly to thesurroundings of the individual receiving treatment, without limitation.These surroundings include but are not limited to a hospital, a clinic,a bedside, a residence, a battlefield, a trauma center, or a fieldenvironment.

As used herein, “adhesive” refers to any material with adherentproperties used to affix one structure to another, including but notlimited to the source of the substance (synthetic or natural) or thestrength of the adhesion.

As used herein, “wound-proximal membrane” refers to a structure at leastpartially encompassing or covering at least one wound site withoutlimitation to the nature of the material used for its construction andmay or may not partially encompass some aspect of the “base”, be thatmaterial synthetic or natural, and without limitation to its physicalattributions including hardness, thickness, height, width, depth, shape,or transparency.

As used herein, “base” refers to a component of a device that is incontact with the subject or a wound-proximal membrane, and the housingelement. In one embodiment, the base element is separable from thehousing element. In another embodiment, the base element is integratedwith the housing element. In one embodiment, base element B (FIG. 1) hasadhesive properties on its underside so that it adheres in a waterprooffashion to wound-proximal membrane C (FIG. 1) or to the patientdirectly, and has a waterproof locking mechanism that joins it to upperhousing element A (FIG. 1), thereby permitting removal of the upperhousing element, without limitation to the structural elements of thisconnection. In one embodiment, the connection between the base and upperhousing element may comprise a screw structure. In one embodiment, theconnection between the base and upper housing element may comprise aclasp structure. In one embodiment, the connection between the base andupper housing element may comprise an interlocking structure. In oneembodiment, the connection between the base and upper housing elementmay comprise an interlocking collar-and-sleeve structure. In oneembodiment, the connection between the base and upper housing elementmay comprise a ball-and-socket structure. In some embodiments, theconnection between the base and upper housing element may form awatertight seal. The identity of the base element is not limited by thenature of the material used for its construction, be that materialsynthetic or natural, and without limitation to its physicalattributions including hardness, thickness, pliability, height, width,depth, shape, diameter, or transparency.

As used herein, “housing” refers to a component of a device thatcompletely or partially defines a chamber continuous with a wound site.The housing may or may not have one or more orifices that serve to allowconnections between other structures of the device. The identity of thehousing element is not limited by the nature of the material used forits construction, be that material synthetic or natural, and withoutlimitation to its physical attributions including hardness, thickness,pliability, height, width, depth, shape, diameter, or transparency.

As used herein, “dock” refers to an orifice in a housing element thatserves as a means of connection between structures or elements of adevice used for contained pulse lavage irrigation, or containedpressurized non-pulsatile irrigation or removal of material from thechamber continuous with the wound site, without limitation to thestructural elements of this connection. In one embodiment, theconnection between the dock and other structural elements may comprise ascrew structure. In one embodiment, the connection between the dock andother structural elements may comprise a clasp structure. In oneembodiment, the connection between the dock and other structuralelements may comprise an interlocking structure. In one embodiment, theconnection between the dock and other structural elements may comprisean interlocking collar-and-sleeve structure. In one embodiment, theconnection between the dock and other structural elements may comprise aball-and-socket structure. In some embodiments, the connection betweenthe dock and other structural elements may form a watertight seal. Theidentity of a dock element is not limited by the nature of the materialused for its construction, be that material synthetic or natural, andwithout limitation to its physical attributions including hardness,thickness, pliability, height, width, depth, shape, or transparency.

As used herein, “port” refers to a structural element that fits into thedock and may allow the introduction of pulse lavage irrigation, orpressurized non-pulsatile irrigation, into the housing chambercontiguous with the wound, or removal of material from the housingchamber, or serve another function related to the use of the device. Inone embodiment, the port may comprise a nozzle that allows theintroduction of pulse lavage irrigation, or pressurized non-pulsatileirrigation into the housing chamber contiguous with the wound. In oneembodiment, the port may comprise a suction nozzle that allows removalof material from the housing chamber contiguous with the wound. In oneembodiment, the port may comprise a plug that fits into a dock andserves to block the orifice of the dock in order to prevent the effluxof material from the housing chamber. In one embodiment, the plug maycontain one or more perforations or hole to allow ventilation during theuse of the device. The identity of a port is not limited by the natureof the material used for its construction, be that material synthetic ornatural, and without limitation to its physical attributions includinghardness, thickness, height, pliability, width, depth, shape, ortransparency.

As used herein, “tubing” refers to a structure that provides a means bywhich to introduce material into the chamber continuous with the woundsite, or remove material from the chamber continuous with the woundsite. The identity of a tubing element is not limited by the nature ofthe material used for its construction, be that material synthetic ornatural, and without limitation to its physical attributions includinghardness, thickness, height, pliability, width, depth, shape, diameter,or transparency.

As used herein, “machine,” when used in reference to a component ofsystems described herein, refers to a structure that propels the fluidinto the tubing and into the chamber and may or may not provide a forcethat removes the fluid from the chamber. The identity of a machine isnot limited by the nature of the material used for its construction, bethat material synthetic or natural, and without limitation to itsphysical attributions including hardness, thickness, height, pliability,width, depth, shape, or transparency

As used herein, “irrigation fluid” refers broadly to any materialintroduced into the chamber continuous with a wound site during theapplication of contained pulse lavage irrigation, or containedpressurized non-pulsatile irrigation. In one embodiment, the irrigationfluid is a gas. In a preferred embodiment, the irrigation fluid is aliquid. The irrigation fluid is not limited to any particular type orcomposition, including normal saline solution, buffer solution,antibiotic solution, bacteriostatic solution, antiseptic solutionincluding Betadine® solution, surfactant solution, soap solution, or anycombination thereof. In one embodiment, the irrigation fluid is normalsaline. The irrigation fluid may include additional agents administeredfor therapeutic or analgesic properties including but not limited tothrombin, analgesic agents, growth factors, collagen-active agents, or acombination thereof. The irrigation fluid is not limited by the volumeadministered during each incidence of therapy which may comprise atleast 0.01-0.1 L; 0.1-0.5 L; 0.5-1 L; 1-2 L; 2-3 L; 3-4 L; 4-5 L; 5-10L; 10-20 L; 20-30 L; 30-40 L; 40-50 L; 50-100 L. The irrigation fluid isnot limited by the nature of its physical attributes including but notlimited to viscosity, color, transparency, temperature, pH, or density.

SUMMARY OF THE INVENTION

The invention provides systems, devices, and methods for theadministration of pulse lavage irrigation or pressurized non-pulsatileirrigation to a subject that limits contamination of the surroundingenvironment. The invention is not limited to the location, type, size,or shape of the wound, and may be applied regardless of the surroundingenvironment of the subject.

In some embodiments, the invention comprises a wound-proximal membranethat provides a surface amenable to attachment of a base member of thedevice. In some embodiments, the wound-proximal membrane at leastpartially encompasses at least one wound site to which pulse irrigationlavage is to be directed. In some embodiments, the wound-proximalmembrane protects the tissue surrounding the wound from maceration ordamage during the pulse lavage irrigation procedure.

In some embodiments, the base member is affixed securely to thewound-proximal membrane. In some embodiments, dressing material at leastpartially encompasses the base member. In some embodiments, a housingelement is securely and reversibly attached to the base member. In someembodiments, the attachment forms a watertight seal. In someembodiments, the housing element and the base element are combined intoone element. In some embodiments, the housing element bears at least onedock serving as an introduction means for a port structure through whichpulsed lavage irrigation fluid or pressurized non-pulsatile irrigationis introduced, or material is removed. In some embodiments, the portstructure through which pulsed lavage irrigation fluid or pressurizednon-pulsatile irrigation is introduced is a nozzle. In some embodiments,the port and dock form a watertight seal. In some embodiments, the atleast one port and at least one dock comprise a structure permittingbetween 1° and 360° rotation of the nozzle. In some embodiments, thestructure permitting between 1° and 360° rotation of said nozzlecomprises a ball-in-cup design.

In some embodiments, the housing element bears at least one port throughwhich irrigation fluid is removed. In some embodiments, the portinterfaces with a dock. In some embodiments, the at least one port anddock form a watertight seal. In some embodiments, the removal ofirrigation fluid occurs via mechanically-induced suction. In someembodiments, the removal of irrigation fluid occurs withoutmechanically-induced suction. In some embodiments, the force or rate ofsuction is adjustable so as to optimize the rate of irrigation fluidremoval. In some embodiments, the port structure through which materialis removed is a nozzle that may move vertically into and out of thewound, as well as rotate up to 360 degrees, thus permitting the nozzleto remove material directly from the wound surface. In variousembodiments, the upper housing element, base element, and wound-proximalmembrane are of dimensions capable of encompassing wounds of at least0.5 cm; 0.5-1 cm; 1-5 cm; 5-10 cm; 10-20 cm; 20-50 cm; 50 cm-1 m; 1m-1.5 m; 1.5-2 m; or 2-3 m. In various embodiments, the upper housingelement, base element, and wound-proximal membrane are of dimensionscapable of encompassing wounds of various shapes, including but notlimited to circular wounds (e.g., puncture wounds, burns, abrasions,penetration wounds, gunshot wounds); linear wounds (e.g., cuts, slices,incisions, lacerations, blade-induced wounds); wounds with irregularshape (e.g., bedsores, ulcers, lacerations, tears, burns, abrasions).

In some embodiments, the housing element bears an additional at leastone dock for optimal positioning of irrigation fluid introduction meansand suction directionality. In some embodiments, unused docks are sealedwith a plug. In some embodiments, the at least one plug and dock forms awatertight seal. In some embodiments, the structures comprising anirrigation fluid introduction means and irrigation fluid suction meanscomprise tubing. In some embodiments, there is a plurality of saidtubing elements to permit multiple points of irrigation fluidintroduction and/or irrigation fluid suction. In some embodiments, thereis a connection means to bundle a plurality of irrigation fluidintroduction or irrigation fluid suction tubing. In some embodiments,the connection means comprises a Y-tube connector. In some embodiments,the connection means comprises a multi-point connector. In someembodiments, the connections between tubing may be reversible, allowingoptimal configuration of the tubing.

In some embodiments, the machine bears at least one place of attachmentfor at least one tubing, without limitation to the structural elementsof this connection. In one embodiment, the connection between the tubingand machine may comprise a screw structure. In one embodiment, theconnection between the tubing and machine may comprise a claspstructure. In one embodiment, the connection between the tubing andmachine may comprise an interlocking structure. In one embodiment, theconnection between the tubing and machine may comprise an interlockingcollar-and-sleeve structure. In one embodiment, the connection betweenthe tubing and machine may comprise a ball-and-socket structure. In someembodiments, the connection between the tubing and machine may form awatertight seal. In some embodiments, the connection between the tubingand machine may form an airtight seal. In some embodiments, the machinehas irrigation pressure controls. The pressure at which the irrigationfluid is applied may be at least 5 psi; 5-7 psi; 7-10 psi; 10-15 psi;15-20 psi; 20-25 psi; 25-30 psi; 30-40 psi; 40-50 psi; 50-75 psi; or75-100 psi. In some embodiments, the pressure at which the irrigationfluid is applied is manually or automatically selected (e.g. based onselected criteria (e.g. wound depth, would type, wound size, patientage, patient size, etc.)). In some embodiments, the pressure at whichthe irrigation fluid is applied is selected from a range (e.g. 5-40 psi,10-30 psi, 25-75 psi, 60-100 psi, 15-85 psi, etc.) within the range of5-100 psi. In some embodiments, the machine has irrigation pulsefrequency controls. The frequency at which the irrigation is pulsed maybe at least 1 pulse per second (e.g. 1-2 pulses per second, 2-5 pulsesper second, 5-10 pulses per second, 10-20 pulses per second, 20-50pulses per second, 50-100 pulses per second, etc.). In some embodiments,the irrigation is pulsed at regular or non-regular intervals. In someembodiments, the machine has a setting that allows continuousnon-pulsatile lavage. In some embodiments, the machine has a settingthat allows control over the flow rate of irrigation fluid. In someembodiments, the flow rate at which the irrigation is applied is atleast 0.05 liters per minute (e.g. 0.05-0.10 liters per minute,0.10-0.25 liters per minute, 0.25-0.50 liters per minute, 0.50-1.0liters per minute, 1-2 liters per minute, 2-5 liters per minute, 5-10liters per minute). In some embodiments, optimal flow rate is manuallyor automatically adjusted. In some embodiments, the machine has asetting that allows control over the force of suction. In someembodiments, the suction pressure is at least 1 mm hg (e.g. 1-10 mm hg,10-25 mm hg, 25-50 mm hg, 50-100 mm hg, 100-150 mm hg, 150-200 mm hg,200-300 mm hg, 300-400 mm hg, 400-700 mm hg, 700-1000 mm hg, etc.). Insome embodiments, the machine has a setting that allows the irrigationand suction to occur automatically. In some embodiments, the machine hasa setting that allows the movement of the suction and irrigation portsto occur automatically. In some embodiments, the machine is powered bybatteries. In some embodiments, the machine is powered by an externalpower source.

In some embodiments, the present invention provides a system for woundirrigation comprising (a) a wound-proximal membrane element, (b) a baseelement, securable to the wound-proximal membrane element, (c) an upperhousing element, connectable to the base element, and bearing at leastone port element, (d) a fluid introduction means, connectable to the atleast one port element, and a fluid suction means, connectable to the atleast one port element. In some embodiments, the fluid comprisesirrigation fluid. In some embodiments, the at least one port elementcomprises at least two port elements. In some embodiments, the fluidintroduction means is connected to one port element and the fluidsuction means is connected to a second port element. In someembodiments, the system further comprises a means of adjusting of fluidpressure. In some embodiments, the system further comprises one or moreirrigation nozzles for directing the flow of the fluid onto the wound.In some embodiments, the spray direction of one or more irrigationnozzles is manually controllable. In some embodiments, the spraydirection of one or more irrigation nozzles moves according to a pre-setprogram. In some embodiments, the upper housing element connects to thebase element by an interlocking mechanism. In some embodiments, theupper housing element connects to base element by a screw-in mechanism.In some embodiments, the base element securably attaches to thewound-proximal membrane element by an adhesive. In some embodiments, thebase element securably attaches to the wound-proximal membrane elementby a locking mechanism. In some embodiments, the wound-proximal membraneelement adheres to a subject proximal to a wound on the subject.

In some embodiments, the present invention provides a method foradministering an irrigation fluid to a wound comprising: (a) placing thesystem on the wound of a subject, (b) administering irrigation fluids tothe wound, and (c) sequestering the irrigation fluids by the systemfollowing contact with the wound. In some embodiments, the irrigationfluid is administered via pulse lavage irrigation. In some embodiments,the irrigation fluid is administered via pressurized non-pulsatileirrigation.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of the invention as shown in FIG. 1 contains the followingelements as described herein. In some embodiments, an irrigation deviceor system of the present invention comprises an upper housing, baseelement, and wound-proximal membrane. The system/device may alsocomprise an irrigation device, waste removal/storage device, pressuregauge, etc. It should be understood that this is an exemplary embodimentand that the invention is not limited to the specific features of thisembodiment. In some embodiments, two or more of the elements of FIG. 1are contained within a single element (e.g. upper housing element andbase element, base element, and wound-proximal element, upper housingelement, base element, and wound-proximal element). In some embodiments,the irrigation device is configured to engage and disengage the upperhousing element. In some embodiments, the irrigation device and theupper housing element comprise a single unit. In some embodiments, thesuction means is configured to engage and disengage the upper housingelement. In some embodiments, the suction means and the upper housingelement comprise a single unit.

Structural element C: A wound-proximal membrane. In some embodiments,the wound-proximal membrane comprises one or more membranes, sheets,films, and/or layers which contact the subject, wound, an/or areasurrounding the wound to present a working field to the other portionsof the device/system. The wound-proximal membrane may comprise differentlayers which are adhesive, fluid resistant, permeable, semi-permeable,impermeable, absorbent, breathable, and/or padded. In some embodiments,the specific make-up of the wound-proximal membrane is selected for thespecific requirements of the subject, wound, and or irrigationprocedure. In some embodiments, the wound-proximal membrane ispermeable, semi-permeable, or impermeable to fluid (e.g. body fluids,irrigation fluids, water, etc.). In some embodiments, the wound-proximalmembrane has a cut made in the center and a surrounding area ofincomplete perforations or microperforations (such as is found in piecesof paper to facilitate “tearing along the dotted line”) (SEE FIG. 4).The center cut may be of any suitable shape (e.g. an “x” shape, acircle, a line, etc.) and size. The perforations may be of any suitableconformation (e.g. ordered, random, linear, etc.) and/or number. In someembodiments, a wound-proximal membrane may comprise more than onecenter-cut. The cut is centered over the wound, and an area thatcontours to the wound edges is removed from the membrane, beginning fromthe pre-cut incision. An appropriate size and/or shape of wound-proximalmembrane may be selected to appropriately suit a specific wound. If thewound is large and the base does not encircle the entire wound, the onlyarea of the membrane that should be removed is the area within theperimeter of the base so that the irrigation and suction can take placeunhindered. In some embodiments, only a portion of the wound is revealedto the irrigation fluid from beneath the wound-proximal membrane. Thecut and the perforations facilitate tearing the membrane, or themembrane may be cut or trimmed to fit with scissors or other instrument.Alternatively, the center of the membrane may be trimmed/torn prior toplacement on the patient if necessary. The purpose of the membrane is toprotect the surrounding skin from maceration as well as to create auniform surface upon which the base element may attach. This gives thebase element a closer contour to the shape of the body, and helps sealthe base element. The membrane may be a thin adhesive membrane, or mayalternatively be composed of a thicker padding such as foam or softrubber to help pad the wound edges and even the contour to achieve abetter fit with the base element. The membrane may comprise any suitablematerial or materials (e.g. synthetic materials, natural materials,polymers, fibers, textiles, glass, plastic, metal, etc.). In someembodiments, the wound-proximal membrane is flat and engages the baseelement through suction or an adhesive. In some embodiments, the topside of the wound-proximal membrane comprises a rim element for engagingthe base element (e.g. SEE FIG. 3). In some embodiments, a rim elementand base element engage through an engagement mechanism (e.g. lipstructure) (SEE FIG. 3B). In some embodiments, the rim element of thewound-proximal membrane enhances the seal between the base element andthe wound-proximal membrane. In some embodiments, engagement between thebase element and wound-proximal membrane is sufficient without a rimelement. In some embodiments, negative pressure within the system/deviceenhances the interaction between the wound-proximal membrane and baseelement.

Structural element B: At least one base element is placed over the woundsite. Alternatively, the at least one base element may be placed on themembrane before the housing element is placed on the wound.Alternatively, the base element is placed directly on or around thewound. The base element may adhere to the wound-proximal membrane via anadhesive surface on its underside. In some embodiments, the base elementdoes not have to encircle the entire wound site, but should be locatedat least partially over the wound. In some embodiments, the base elementsurrounds the wound. Both the base element and the wound-proximalmembrane are intended to remain on the wound site as long as the deviceis used, but may be replaced as necessary. The base element may havesolely adhesive on its underside, or adhesive padding such as a softrubber, silicone, or water-proof foam. The base element may be of anysuitable shape (e.g. circular, ovular, square, rectangular, etc.) orsize to best interact with the other elements of the device (e.g. upperhousing and wound-proximal membrane) and properly engage the wound. Insome embodiments, the inner diameter or perimeter of the base element isconfigured and sized for interaction with a upper housing element. Insome embodiments, the outer diameter or perimeter of the base element isconfigured and sized for interaction with a upper housing element. Insome embodiments, the inner diameter or perimeter of the base element isconfigured and sized for interaction with a wound-proximal membrane. Insome embodiments, the outer diameter or perimeter of the base element isconfigured and sized for interaction with a wound-proximal membrane. Thebase element may be of any suitable shape and size. In some embodiments,the shape and size of the base element is selected based oncase-specific criteria (e.g. wound size, wound shape, patient size,wound location, etc.).

Additional adhesive dressing or membrane may be placed around theperimeter lip of the base, to further seal it onto the wound-proximalmembrane and to prevent the escape of irrigation fluid. This may alsoremain in place as needed. The additional dressing may have a pre-cutorifice that conforms to the outer perimeter lip of the base element,and should be attached after the base is placed on the other adhesivedressing.

Structural element A: The upper housing element. In some embodiments,the upper housing element is temporarily secured to the base element toform a watertight junction. In some embodiments, the upper housingelement provides entry and exit points (e.g. ports, valves, etc.) forirrigation fluid (SEE FIG. 1). In some embodiments, the upperhousingelement may be of any suitable shape (e.g. dome (SEE FIG. 2), flat (SEEFIG. 6A/B, pyramidal (SEE FIG. 6C), etc.) and size. In some embodiments,the shape and size of the upper housing is selected based oncase-specific criteria (e.g. wound size, wound shape, patient size,wound location, etc.). In some embodiments, the shapes and sizes of theupper housing element, base element, and wound-proximal membrane areselected to complement each other and function in conjunction (SEE FIGS.1, 2, 3, and 6).

Different embodiments for the junctions between the upper housing, baseelement, and wound-proximal membrane are exemplified in FIG. 2 and FIG.3. Examples of the upper housing and base element junction include screw(SEE FIG. 2A), snap, fit (SEE FIG. 2C), lock, or clasp mechanisms (SEEFIG. 2B), or other means that provide for a watertight junction (e.g.temporary watertight junction). The inferior bottom of the upper housingelement may rest within the inner perimeter of the base, with thelateral bottom of the upper housing element resting on top of the base.The upper housing element may be removed from the base element betweenuses to allow the wound to be dressed in any manner desired. In someembodiments, the junction between the upper housing and the base elementis configured for routine and repeated engagement and disengagement. Insome embodiments, the upper housing comprises 1 or more docks or ports(e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . . . 20, etc.) for engagement ofother device elements including, but not limited to means for providingirrigation fluid, suction means, etc. In some embodiments, docks and/orports are generically configured for attachment to any additional deviceelements. In some embodiments, ports and/or docks are configured forattachment to a specific element (e.g. irrigation menas, suction means,pressure monitoring means, etc.).

Additional structural elements, as described herein:

The suction tubing (SEE FIG. 5A), irrigation nozzle(s) (SEE FIG. 5B/C),and plug(s) (SEE FIG. 5D) may be attached to the upper housing elementeither before or after it is secured to the base element. When aplurality of docks is present, these accessories can be interchangeablyand reversibly placed within the various docks in order to optimizesuction and irrigation. In a preferred embodiment, the seal between thedocks and accessories is watertight and/or airtight.

The suction and irrigation tubing is secured at one end to theirrigation nozzles and suction nozzles, and at the other end to themachine(s). The tubing may be separated from the upper housing elementand the machine(s) between uses to prevent contamination. The connectionbetween the nozzle or other irrigation fluid introduction structure andthe tubing as well as the connection between the machine(s) and thetubing is secure enough to withstand movement but also easily released.If more than one suction tube or irrigation nozzle is to be used on theupper housing element, Y tubing or a multi-point connection can be usedto attach multiple nozzles or suction tubes to the upper housingelement. In some embodiments, suction and/or irrigation tubing containsone or more valves, ports, splitters, etc. In some embodiments, suctionand/or irrigation tubing is attached to the upper housing elements atone or more ports and/or docks (e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 . . .20, etc.). In some embodiments, the present device comprising tubing ofany suitable configuration required for the specific irrigation task.

After connecting the machine to a supply of irrigation fluid, themachine is turned on, and the irrigation is controlled by aiming theflow via manual manipulation of irrigation nozzle(s). In an alternativeembodiment, the movement of the irrigation nozzles and suction nozzlesis automated. The irrigation nozzle(s) has 360° rotational movementwithin the upper housing element. In one embodiment, this freedom ofmovement is provided by a “ball in cup” design. This freedom of movementallows targeted pulse irrigation for optimized removal of biofilm. Inone embodiment, fluid is removed by manipulating the suction ports,which have free vertical movement and at least some horizontal movement.In some embodiments, the machine which supplies irrigation fluidcomprises a single unit with the upper housing element. In someembodiments, the machine to a supply of irrigation fluid engages theupper housing element at an irrigation hose or tube, dock, port, and/orinlet valve.

After sufficient irrigation, the upper housing element and tubing areremoved, and the wound covered and dressed per routine. In someembodiments, the pulse irrigation and/or suction machines are re-usableand when properly used do not result in cross-contamination betweenpatients. In an alternative embodiment, the machine is disposable. Insome embodiments, the wound-proximal membrane, dressing, and all othercomponents of the device are disposable and are discarded after thepatient has completed therapy. In one embodiment, the disposablecomponents are packaged together and the machine(s) are packagedseparately.

Wound-proximal membrane, base element(s), and upper housing element(s)are available in a variety of sizes and shapes (e.g. circular, ovular,square, rectangular, etc.) to allow optimal irrigation on differentwound sites regardless of anatomical position or size of the wound. Insome embodiments, a kit is provided containing a plurality of componentsof different sizes and shapes that can be mixed and matched as needed.

In some embodiments, the upper housing element, base element, andwound-proximal membrane are of dimensions capable of encompassing woundsof a variety of diameters. In some embodiments, the upper housingelement, base element, and wound-proximal membrane are of dimensionscapable of encompassing wounds of a variety of shapes.

In some embodiments, the upper housing element and base element areconstructed to permit the application of negative pressure to the wound.In some embodiments, absorbent material (e.g., sponge, etc.) is includedwithin the wound-proximal chamber. In some embodiments, negativepressure is applied to the wound by the application of suction. Infurther embodiments, excess fluid or wound-produced fluid is removedthrough a nozzle that may move vertically into and out of the wound,thus permitting the nozzle to remove material directly from the woundsurface.

In some embodiments, a system is provided comprising one or more of theabove components as well as, optionally, instructions for use, computerequipment and software, or other components for using, monitoring, orautomating one more or more components of the system.

1. A system for wound irrigation comprising: a) a wound-proximalmembrane element; b) a base element, securable to said wound-proximalmembrane element; c) an upper housing element, connectable to said baseelement, and bearing at least one port element; d) a fluid introductionmeans, connectable to said at least one port element; and e) a fluidsuction means, connectable to said at least one port element.
 2. Thesystem of claim 1, wherein said fluid comprises irrigation fluid.
 3. Thesystem of claim 1, wherein said at least one port element comprises atleast two port elements.
 4. The system of claim 3, wherein said fluidintroduction means is connected to one said port element and said fluidsuction means is connected to a second said port element.
 5. The systemof claim 1, further comprising a means of adjusting of fluid pressure.6. The system of claim 1, further comprising one or more irrigationnozzles for directing the flow of said fluid onto said wound.
 7. Thesystem of claim 6, wherein the spray direction of said one or moreirrigation nozzles is manually controllable.
 8. The system of claim 6,wherein the spray direction of said one or more irrigation nozzles movesaccording to a pre-set program.
 9. The system of claim 1, wherein saidupper housing element connects to said base element by an interlockingmechanism.
 10. The system of claim 1, wherein said upper housing elementconnects to said base element by a screw-in mechanism.
 11. The system ofclaim 1, wherein said base element securably attaches to saidwound-proximal membrane element by an adhesive.
 12. The system of claim1, wherein said base element securably attaches to said wound-proximalmembrane element by a locking mechanism.
 13. The system of claim 1,wherein said wound-proximal membrane element adheres to a subjectproximal to a wound on said subject.
 14. A method for administering anirrigation fluid to a wound comprising: a) placing the system of claimone on the wound of a subject; b) administering irrigation fluids tosaid wound; and c) sequestering said irrigation fluids by said system ofclaim 1 following contact with said wound.
 15. The method of claim 14,wherein said irrigation fluid is administered via pulse lavageirrigation.
 16. The method of claim 14, wherein said irrigation fluid isadministered via pressurized non-pulsatile irrigation.